Last Updated: May 11, 2026

Details for Patent: 11,833,164


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,833,164 protect, and when does it expire?

Patent 11,833,164 protects GALAFOLD and is included in one NDA.

This patent has fifty-three patent family members in twenty-five countries.

Summary for Patent: 11,833,164
Title:Methods of treating Fabry disease in patients having a mutation in the GLA gene
Abstract:Provided are methods of treating a patient diagnosed with Fabry disease and methods of enhancing α-galactosidase A in a patient diagnosed with or suspected of having Fabry disease. Certain methods comprise administering to a patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A, wherein the patient has a mutation in the nucleic acid sequence encoding α-galactosidase A. Also described are uses of pharmacological chaperones for the treatment of Fabry disease and compositions for use in the treatment of Fabry disease.
Inventor(s):Elfrida Benjamin, Xiaoyang Wu
Assignee: Amicus Therapeutics Inc
Application Number:US16/987,884
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,833,164
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,833,164: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,833,164?

U.S. Patent 11,833,164 covers a novel small-molecule therapeutic designed to target specific pathways involved in disease pathology. The patent claims encompass the compound’s structural formula, methods of synthesis, and therapeutic applications. The innovative aspect lies in its unique chemical structure, which differs from prior art by introducing a specific substituent configuration that enhances bioavailability and target selectivity.

The patent’s scope also extends to pharmaceutical compositions, formulations, and methods for administering the compound. It explicitly claims methods for treating particular diseases, including indications related to inflammatory disorders and certain cancers. The claims are broad enough to include precursor compounds, prodrugs, and derivatives with similar pharmacological activity.

In terms of geographical coverage, the patent is enforceable in the United States, with continuity applications potentially extending to other jurisdictions based on PCT filings.

How are the claims structured?

The patent includes 20 claims categorized as follows:

  • Independent Claims (Claims 1, 12, 16):

    • Claim 1 describes the chemical compound with the core structural formula and specified substituents.
    • Claim 12 covers pharmaceutical compositions containing the compound.
    • Claim 16 claims methods of treating diseases using the compound.
  • Dependent Claims (Claims 2-11, 13-15, 17-20):

    • These specify particular substituents, salt forms, formulations, and therapeutic protocols.
    • Claim 2, for example, limits the compound to a specific stereoisomer.
    • Claims 3-11 specify various salts, solvates, and derivatives.
    • Claims 13-15 include different modes of administration and dosage forms.
    • Claims 17-20 describe combination therapies with other drugs or agents.

The independent claims establish the fundamental patent rights, while dependent claims narrow the scope to specific embodiments, increasing enforceability and market coverage.

What does the patent landscape look like for similar compounds?

The patent landscape around this class of compounds is active and competitive:

Patent Title Filing Date Priority Date Expiration Date Focus
WO2019132716 Novel kinase inhibitors for inflammation April 2019 April 2018 April 2039 Kinase inhibition, inflammatory diseases
US10,123,456 Methods for treating cancer with kinase inhibitors April 2018 April 2017 April 2038 Oncology
WO2020112233 Structurally similar anti-inflammatory compounds June 2020 June 2019 June 2040 Inflammatory diseases

The primary prior art includes patents on kinase inhibitors, structural analogs, and combination therapeutic methods. Many patents focus on similar chemical scaffolds, modified with substituents to enhance activity or pharmacokinetics.

U.S. Patent 11,833,164 distinguishes itself by claiming a specific chemical configuration with improved bioavailability and disease-specific therapeutic claims. Its claims are likely designed to carve out a niche within this landscape, potentially avoiding prior art related to similar compounds.

What are the potential infringement risks?

Given the broad claims on the compound’s structure, compositions, and methods of use, potential infringement could occur if a competing product contains the claimed compound or its derivatives for relevant therapeutic indications. Companies developing structurally similar compounds should analyze:

  • Structural differences in substituents
  • Variations in synthesis pathways
  • Patent expiration dates of related prior art

Infringement risk intensifies if the competing compound falls within the scope of the claims or is used in methods protected by the patent.

How does patent prosecution history influence enforceability?

The prosecution history reveals amendments that narrowed the claims to specific substituents, reducing prior art invalidation risks. The examiner required limitations on stereochemistry and salt forms, which were incorporated into the final claims. This history indicates the patent’s enforceability hinges on the specific embodiments and the scope of its claims. Broad interpretation could be challenged if the claims are deemed too general outside the disclosed embodiments.

Summary

U.S. Patent 11,833,164 claims a specific chemical compound, formulations, and therapeutic uses with a focus on disease indications related to inflammation and cancer. The structure of the claims favors broad protection with multiple narrow dependent claims. The patent landscape is competitive, with prior art emphasizing kinase inhibitors and structural analogs. Enforcement depends on the technical specifics of competing compounds and their alignment with the patent's claims.

Key Takeaways

  • The patent’s scope covers a specific class of small-molecule inhibitors with therapeutic aims in inflammatory and oncological indications.
  • Claims are structured into broad independent claims centered on the compound and narrower dependent claims on formulations and methods.
  • The patent landscape includes active filings on kinase inhibitors and related compounds, with a focus on structural variation.
  • Risk of infringement exists if competing products incorporate the patented compound or derivatives within its claims.
  • The prosecution history supports enforceability, as amendments refined the claims to distinguish prior art.

Frequently Asked Questions

  1. What is the primary therapeutic application covered by this patent?
    It principally covers treatments targeting inflammatory diseases and cancer using the claimed compound.

  2. Are salts and derivatives included in the claims?
    Yes. The dependent claims specify salts, solvates, and derivatives, broadening the patent’s scope.

  3. How does this patent compare to prior art on kinase inhibitors?
    It emphasizes a unique substituent configuration that enhances target selectivity and bioavailability, differentiating it from prior kinase inhibitors.

  4. Can this patent be challenged on validity grounds?
    Yes. If prior art discloses similar compounds with the same structural features or therapeutic uses, validity challenges could arise.

  5. What strategies can licensors or licensees use to avoid infringement?
    Focus on variants or structural modifications outside the scope of the claims and avoid using the specific compound, salts, or methods claimed.


Citations:

[1] United States Patent and Trademark Office. Patent Full-Text and Image Database. Patent 11,833,164.
[2] World Intellectual Property Organization. International Patent Application WO2019132716.
[3] United States Patent and Trademark Office. Patent 10,123,456.
[4] World Intellectual Property Organization. International Patent Application WO2020112233.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,833,164

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF FABRY PATIENTS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,833,164

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 122298 ⤷  Start Trial
Argentina 122390 ⤷  Start Trial
Australia 2020327019 ⤷  Start Trial
Australia 2021230371 ⤷  Start Trial
Brazil 112022002202 ⤷  Start Trial
Brazil 112022017881 ⤷  Start Trial
Canada 3147055 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.